Early Alert: WATCHMAN Access System Safety Issue and the Importance of Medical Device Recalls

Medical device safety is a critical concern for healthcare providers and patients alike. Recently, the FDA issued an early alert regarding a potentially high-risk issue with certain WATCHMAN Access Systems from Boston Scientific. This notice highlights the importance of staying informed about device recalls, understanding the risks, and taking prompt action to protect patient safety. At KBD we closely monitor medical device recalls and provide guidance on potential legal implications for affected patients.

What Happened: The WATCHMAN Access System Advisory

On July 30, Boston Scientific sent a communication to healthcare providers and facilities using the WATCHMAN Access Systems, recommending updates to device instructions for use (IFUs). The alert focuses on the risk of air embolism during procedures performed without positive pressure-controlled ventilation.

The WATCHMAN Access Systems are used to provide vascular and transseptal access for the WATCHMAN FLX Left Atrial Appendage Closure Devices. These procedures are typically performed on patients with atrial fibrillation to reduce the risk of stroke. While the devices are life-saving, certain procedural factors can increase the likelihood of complications.

According to Boston Scientific and the FDA, patients undergoing procedures with deep or conscious sedation—rather than general anesthesia—may be at higher risk for negative left atrial pressures, especially if they are hypovolemic or have partial upper airway obstruction. Negative pressures in the left atrium can allow air to enter through the hemostasis valve during device insertion, removal, or exchanges, potentially leading to air embolism.

Reported Injuries and Risks

As of the alert, Boston Scientific has reported 120 serious injuries and 17 deaths linked to this issue. Complications can include:

• Arrhythmia

• Hemodynamic collapse

• Stroke (CVA)

• Other end-organ failure caused by ischemia

These risks are acute and occur during the implant procedure. Patients with previously implanted WATCHMAN devices are not considered at additional risk and should continue routine follow-up care as advised by their physicians.

Recommended Actions for Healthcare Providers

The early alert advises clinicians to:

1. Review updated IFUs related to air embolism.

2. Adjust procedural techniques to minimize negative atrial pressures, such as:

   • Ensuring patients are not hypovolemic.

   • Keeping the access system valve below heart level or under fluid during insertion.

   • Slowly withdrawing devices near the valve and timing exchanges during expiration.

3. Notify all clinicians and facilities that perform WATCHMAN procedures, including any sites where affected devices were transferred.

4. Return acknowledgment forms to Boston Scientific confirming receipt and implementation of safety updates.

Healthcare providers are urged to forward this notice to anyone in their network using these devices, ensuring that the medical device advisory reaches the end-user level.

Understanding Medical Device Recalls

The WATCHMAN Access System alert underscores a broader point: medical device recalls are an essential part of patient safety and healthcare quality control. The FDA, along with manufacturers, issues recalls, alerts, and safety communications when devices are linked to injuries or deaths. These recalls can be categorized by severity:

• Class I Recall: High risk of serious injury or death.

• Class II Recall: Moderate risk of temporary or reversible health consequences.

• Class III Recall: Low risk; usually involves labeling or minor defects.

Medical device recalls can arise from manufacturing defects, software issues, labeling errors, or unforeseen complications during use. In the case of the WATCHMAN Access Systems, the recall is precautionary, aimed at updating instructions and training to prevent air embolism events.

The Role of Legal Advocacy

At KBD Attorneys we focus on representing patients harmed by defective or recalled medical devices. When a device is associated with serious injury or death, affected patients and families may have grounds to pursue compensation. Our team has extensive experience handling product liability and medical device litigation, ensuring manufacturers are held accountable when safety warnings are ignored or when defects lead to harm.

We also regularly post blogs on medical device recalls, providing updates, safety guidance, and links to FDA alerts. Recent posts have covered issues including:

• Philips Respironics BiPAP Ventilators Recall

• Urgent Recall: HeartSine Samaritan Defibrillators

• Smith Medical Device Recall

These blogs highlight the real-world consequences of device defects and underscore the importance of timely awareness and legal oversight.

WATCHMAN Recall: Key Takeaways for Patients and Providers

Patients and providers should remain vigilant in response to medical device safety alerts. Key points from the WATCHMAN Access System early alert include:

1. Recognize the Risk – Air embolism is rare but serious, primarily occurring during procedures under sedation without positive pressure ventilation.

2. Follow Updated Instructions – Device manufacturers issue updates to mitigate risks; clinicians must adhere strictly to IFU guidance.

3. Report Adverse Events – Healthcare professionals and patients can report complications to the FDA’s MedWatch program.

4. Know Your Device – The Unique Device Identifier (UDI) system allows clinicians and patients to track individual medical devices, improving safety monitoring and response to potential issues.

Boston Scientific has provided contact information for reporting adverse events: ICardioQAComplaints@bsci.com. Staying in contact with manufacturers and following recommended protocols helps prevent further harm and supports safer outcomes for patients.

Why Early Alerts Matter

Early alerts like this one serve multiple purposes:

• Prevent injuries and fatalities by providing timely safety information.

• Guide healthcare providers on procedural adjustments and risk mitigation.

• Inform patients and allow them to engage in discussions with their care team.

• Facilitate legal accountability if a patient suffers harm despite warnings.

Medical device safety is a collaborative effort between regulators, manufacturers, healthcare providers, and patients. Early awareness and compliance with safety alerts are critical steps in reducing risk and improving outcomes.

Conclusion

The recent WATCHMAN Access System advisory from Boston Scientific is a reminder of the ongoing need for vigilance in medical device safety. With serious injuries and fatalities reported, adherence to updated instructions and careful procedural management can save lives. At KBD we continue to monitor recalls and provide guidance to patients and families affected by defective medical devices. Our recent blogs and resources offer insights into recalls across cardiac, orthopedic, and life-support devices, helping healthcare providers and patients stay informed.

If you or a loved one has been affected by a medical device issue, it is crucial to seek both medical attention and legal advice promptly. Understanding your rights and the steps to take after a recall can make a meaningful difference in both health outcomes and potential compensation for injuries caused by defective devices.

Contact KBD Attorneys if you have been injured by a defective medical device.